福安藥業(300194.SZ):天衡製藥的枸櫞酸託法替布原料藥通過CDE審批
格隆匯3月28日丨福安藥業(300194.SZ)公佈,公司全資子公司福安藥業集團寧波天衡製藥有限公司(簡稱“天衡製藥”)於近日在國家藥品監督管理局藥品審評中心(CDE)“原料藥、藥用輔料和藥包材登記信息公示”平台查詢獲悉,天衡製藥提交的“枸櫞酸託法替布”原料藥註冊申請通過了CDE審批。
枸櫞酸託法替布主要適用於甲氨蝶呤療效不足或對其無法耐受的中度至重度活動性類風濕關節炎(RA)成年患者,可與甲氨蝶呤或其他非生物改善病情抗風濕藥(DMARD)聯合使用。
根據公示平台查詢顯示:目前,枸櫞酸託法替布原料藥登記狀態為A的有16家企業。公司上述產品通過CDE審評審批表明產品符合中國藥品審評技術標準,已批准在國內上市制劑中使用。
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